Restoration® Modular Revision Hip System Post Market Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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The purpose of this study is to demonstrate survivorship of the femoral stem at 5 years.

Condition or disease

Intervention/treatment

Arthroplasty, Replacement, Hip

Device: Restoration® Modular Revision Hip System

Detailed Description:

The two-piece modular revision stem components are intended to be used for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. This study evaluates the System in revision cases only. The stems are intended to be used with Stryker Orthopaedics femoral heads, unipolar and bipolar components, and acetabular components. These femoral stems are designed to be press fit into the proximal femur.

In addition to demonstrating survivorship at 5 years, this study will seek to gain information on four secondary objectives: radiographic stability, Harris Hip Scores, SF-36 general well-being assessment, and safety profile.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

18 Years to 85 Years (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Candidates for cementless revision of a failed femoral prosthesis.

Patients willing to sign the informed consent.

Patients able to comply with follow-up requirements including post-operative weightbearing restrictions and self-evaluations.

Male and non-pregnant female patients ages 18 to 85 years of age at the time of surgery.